Change Control, Purpose:
Change Control, The purpose of this SOP is to define the requirements that all planned changes which have potential to impact the quality of the product are controlled through a systematic, standard and effective approach. This approach of controlling change will ensure:
[][]Safeguard of quality (Safety and efficacy of the product)
[][]Ensure compliance with legal and regulatory requirements
[][]Traceability of changes made through the lifecycle of a product or facility
[][]Assessment and management of all risks (Quality, Business and EHS) associated with the implementation of changes.
Change Control, Scope:
Applies to all planned changes (including emergency/temporary/permanent changes) that have the potential to affect GMP, Product Quality, Safety, Efficacy, Stability, EHS and the Validation status of Processes, Facilities and Systems of General Block and Sterile Block at XX Pharmaceuticals Ltd.
[][]Few examples of planned changes within the scope of this SOP are:
Production
GMP Documents :
Validation protocol.
Processes :
[][]Manufacturing or Packaging processes
[][]Process (time, mixing speed, temperature, order of addition etc).
[][]Removal/replacement/addition of API or excipients (Formula amounts, overage)
[][]Batch size, production scale
[][]In process controls
[][]Cleaning methods or processes.
[][]Coating weight of tablets, weight of capsule shell, fill weights or volumes.
[][]Any trial (machine/process) work.
[][]Shelf life, expiry (including hold times at intermediate production stages).
Manufacturing Facilities & Equipment :
[][]Equipment, critical device.
[][]Manufacturing/packaging suite/ location.
[][]Introduction of new product/ machinery.
[][]Change of critical spare parts of machineries.
[][]Product & materials
[][]Shape or dimension of product.
[][]Imprints/embossing or other markings on product.
[][]Colour of the product
[][]Packaging Components
[][]Intermediate/Primary/Secondary packs
[][]Product contact components
[][]Disinfectants / Detergents
[][]Product Contact Lubricants
Quality Assurance
Control Documents :
[][]Specification (product, API, excipients, packaging) and Control Direction
[][]Stability protocol.
[][]Artworks.
[][]Qualification protocol
[][]Technical agreements with third party or any service provider.
[][]Colour shades.
[][]Approved supplier list
Methods & procedure :
[][]Sampling or Testing processes
[][]Test parameters (time, run time, temperature, solvent etc).
[][]Removal/replacement/addition of tests.
[][]Environmental monitoring system.
[][]Microbiological monitoring location, frequency and limits
Facilities & Equipment :
[][]Laboratory equipment.
[][]Critical spare parts of equipment.
[][]Introduction of new equipment.
Supplier :
[][]Supplier of API, excipients or packaging components
[][]Change in supplier, manufacturing location, material, pack size or mode of packaging.
Engineering Services
GMP Documents :
[][]Qualification protocol
[][]Drawing & facility layout
[][]Master Calibration list
Facilities & Equipment :
[][]New/additional location for assembly, manufacturing, packaging and testing.
[][]Building Management e.g. Building Management system, pest control.
[][]Calibration frequency or limits/tolerance.
[][]Utilities such as facilities cleaning, compressed air, vacuum, electricity and water.
[][]Building / structural work (e.g. new facility, or installation of utility equipment).
[][]Any change in equipment design
[][]Substitution of any engineering parts.
Services /Utilities :
[][]Water Generation and Distribution
[][]Steam Generation and Distribution
[][]HVAC, vacuum and compressed air modification
Others
[][]Any change relating to a product manufactured at third party
[][]Change relating to product/technology transfer.
[][]Any activity that have the potential to affect EHS
[][]Format change of any controlled documents such as Batch Manufacturing Record, Batch Packaging Record & Control Direction
The process does not apply to the following as these are managed separately by individual SOPs:
[][]Any unplanned incident/changes
[][]Engineering replacement with identical/equivalent parts (procured from the approved sources having the same functionality , specification and serial number)
[][]Routine servicing or preventive maintenance.
[][]Changes during Product Development/trial
[][]Routine revision of any controlled documents (e.g. SOP, BMR, Test methods etc)
[][]SOP/BMR/BPR change to comply with any requirements where the reason and history of changes are mentioned in the revision details.
[][]Like for Like Change
Definitions / Abbreviation:
[][]Change Control Procedure: A formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system.
[][]Temporary change: A change (departure from any established procedure/system/process) initiated for the evaluation of proposed procedure/system/process, which has been taken with prior approval to achieve the desired output, allowed for one time change and limited to a particular batch or campaign batches. For example change in manufacturing equipment.
[][]Permanent change: A change initiated based upon scientific rational or historical cGMP data or data generated through temporary changes.
[][]Minor Change: A change unlikely to have a detectable impact on the critical attributes of a system, process, material, product or procedure. (For example: equivalent rewording of instructions or batch record format changes
[][]Major Change: A change that could have a significant impact on the critical quality attributes of a system, process, material, product or procedure. (For example: packaging design change, order of addition of components, mixing parameters in a process).
[][]Critical Change: A change that would be likely to have a significant impact on the critical attributes of a system, process, materials, product or procedure. (For example: a change in critical equipment or change in manufacturing site.)
[][]Planned Change: A change that is planned and given the associated lead time.
[][]Unplanned Change: An unplanned change is a change that occurs unexpectedly on an individual batch or process and is documented via the deviation system.
[][]Engineering replacement with identical parts: Parts that meet the following criteria are known as identical parts and replacement for these Change Control is not required:
=>Same functionality.
=>Same specification.
=>Same manufacturer.
=>Same part number.
[][]Engineering replacement with equivalent parts: Parts that meet the following criteria are known as equivalent parts and replacement for these Change Control is not required:
=>Same functionality.
=>Same specification.
=>Could be a different manufacturer.
=>Could be a different part number from the same manufacturer.
Responsibilities:
[][]The roles and responsibility is as follows:
Concern Department (change initiator)
[][]To propose the change.
[][]Assess if the change is within scope of the change control process.
[][]Provide sufficient supporting information necessary for initial assessment of the change.
[][]To intimate Quality Compliance for issuance of the change control form.
[][]To make necessary entries in the change control form.
[][]To take approval of Department Head and send the form to Quality Compliance for review.
[][]To take approval from Manager, Quality Assurance
[][]To take execution approval from Manager, Quality Assurance prior to execute the change.
[][]To generate relevant supporting data in consultation with related department for compliance of the recommendation provided in reference to change implemented.
Quality Assurance Personnel
[][]To make necessary entries in the change control register.
[][]To issue change control form after assigning change control number and making necessary entries.
[][]To review the change control form and provide the recommendations as impact analysis against the change initiated.
[][]To review actionable mentioned in the impact analysis that are required to be in place prior to implement proposed change and to provide execution approval.
[][]To send the change control for approval to Manager, Quality Assurance in case of impact on regulatory aspects and to obtain approval.
[][]To intimate third party for changes related to their products.
[][]To intimate the changes related to customer, in accordance with the provision as defined in the quality agreement.
[][]To generate and issue corrective action and preventive action (CAPA) form if required for recommendations provided to complete the activity in concern to change implemented.
[][]To review and evaluate the data / assessment report generated during study in consultation with Manager, Quality Assurance.
[][]To close the change control after ensuring implementation and to make necessary entries in change control register.
[][]To retain all change controls in Quality Assurance department.
[][]To circulate a list of change controls which are in issued status for follow up and progress review. The list shall be circulated on monthly basis
Concern Department Head
[][]To review and evaluate filled change control form and give approval.
[][]To recommend possible impact in change control form.
[][]To send the filled change control form for review to Quality Compliance.
[][]To revise the document in consultation with all respective department.
[][]To arrange and ensure generation of the supporting data/ assessment report to comply the recommendations.
[][]To take execution approval from Manager, Quality Assurance prior to execution of the changes.
Manager, Quality Assurance
[][]To provide recommendations / review the adequacy of impact analysis for recommendation provided in respect to change initiated.
[][]To decide change review level of changes proposed.
[][]To approve the change control.
[][]Ensure all relevant changes are managed according to SOP.
[][]Trending of change controls.
[][]Assess, review and approve a proposed change for implementation
Procedure:
Checking of scope for Planned Change:
[][]Before initiating the process the initiator will check if the planned change is within the scope defined in this SOP. If there is any doubt about the scope of change then the initiator will discuss with Quality Assurance Department.
[][]Before initiating the proposal the initiator will check whether any change proposal on the similar subject (Product/equipment/process/materials) still remains open that need to be implemented.
Procedure for Change Initiation :
[][]Upon identification of need of change(s), concern person shall ask Quality Assurance personnel to issue “Change Control Form” (Refer Annexure-I).
[][]Quality Assurance personnel shall make following entries in “Change Control Form” while issuance and similar entries in “Change Control Register” (Refer Annexure-II).
[][]Change Control No. :
[][]Change control No. shall be assigned as per below explained numbering system.
[][]Change control number shall be changed every year.
[][]Change control number shall be alphanumeric system containing 11 characters. Numbering breakdown is as follows: CCyy/Area code/xxx.
Area Code is as follows:
=>General Issues GI, Common issues that affects more than one area.
=>General Block : GB
=>Sterile Block : SB
=>For example: CCXX/GB/001.
[][]The first two alphabets shall stand for Change control
[][]Next two numeric characters shall stand for year code XX shall denote year 20XX.
[][]Next character is slash (/), followed by two capital letter stands for area code of General Block at XX Pharmaceuticals Ltd.
[][]Next character is slash (/), followed by three numerical shall stand for serial number, which shall start every year from 001. For example first change control no CCXX/GB/001 and second CCXX/GB/002, third CCXX/GB/003 ….. for any change.
[][]In case of Sterile block, Change control number shall be SC13/CB/001 and so on. Two capital letter CB stands for area code of Sterile block at XX Pharmaceuticals Ltd.
[][]The number will be unique; if proposal is withdrawn/ rejected the same number will never be used again.
[][]Initiator: Name of the person to whom the change control is issued shall be written.
[][]Originating Department: The name of the department to whom the change control is issued shall be written.
[][]Issued By: The Quality Assurance Personnel who is issuing the change control shall put his/her initial with signature.
[][]Date of Issuance: Date on which the change control is issued shall be written.
[][]Product / Material / Document Name / SOP Title: Name of product/ material/ document title whatever applicable shall be mentioned for which the change is initiated and rest shall be stricken out.
[][]Batch no. /Lab control no. / Document No. : In case of temporary change, batch number of the product or Lab control No. of material for which the change is initiated shall be written.
In case of permanent change, document number (Master BMR No., SOP No., Specification No. etc. with version number) for which change is initiated shall be written.
[][]Type of Product (Country): Whether product is for domestic market or export market shall be mentioned. Specify the name of country as applicable, If the change is related to export product, name of region or country for which the product is being manufactured shall be mentioned.
[][]Change Type: Put the tick mark on appropriate change type.
[][]Concern person shall further fill the change control form as explained under below. In case space provided in change control form is not sufficient to accommodate the changes, below details shall be given on separate sheet in following type of table. This attachment shall be prepared and checked by concern department and reviewed by Quality Assurance.
| Sl. No. | Existing System | Proposed Change | Reason/ Justification | Impact analysis | Change review level |
|---|---|---|---|---|---|
| Prepared by/date (Change Initiator ) | Checked by/date: (Department Head) | Reviewed by/date: (Manager, Quality assurance) |
[][]Existing System: Write details of existing process / formula / procedure / equipment or specification that is being followed.
[][]Description of Proposed Change: Write details of proposed process / formula / procedure / equipment or specification that is to be followed.
[][]Reason/Justification/Benefits for proposed change :In case of Direct Change, write the clear reason (wherever possible) for change initiated along with justification based on supporting data like history, trend, stability data, scientific rationale, event / audit observations and experience or any other to ensure no adverse impact on product quality.
[][]Temporary changes: Confirm that a search for similar changes been performed. Put the tick mark on appropriate box and write the date of expiry for temporary change.
Evaluation for Requirement of Change: If not justifiable
[][]The filled change control shall be reviewed by Concern Department Head and Manager, Quality Assurance or Designee. If the requirement for change is not justifiable or not agreed, either to Concern Department Head or Manager, Quality Assurance or Designee, they shall include justification to close the change control.
[][]The change control form and register shall be updated for closure by Quality Assurance personnel and change control form shall be retained in Quality Assurance department.
[][]Evaluation for Requirement of Change: If justifiable.
[][]Upon evaluation, if the requirement for change is justifiable or agreed, Concern Department Head and Quality Assurance personnel, they shall further allow carrying forward change control by signing it, for approval of GM, Plant and Manager, Quality Assurance.
Recommendations for Impact Analysis :
[][]Concern Department Head and Manager, Quality Assurance or his Designee shall provide recommendations for impact analysis to support ultimate output.
[][]The respective impacted Department Head shall be informed for the recommendations provided under each impact and approval for the same shall be taken from the impacted Department Head.
[][]Change control shall be informed to customer, in accordance with the provision as defined in the quality agreement.
[][]Based on feedback obtained further course of change control implementation shall be decided.
[][]If change control is not approved by third party or not acceptable to third party as per quality agreement, then change control shall be closed with the justification that particulate batch cannot be dispatched to respective third party but it can be sent to different third party if it fulfills requirements of different third party.
[][]If that particular drug product has to be dispatched to the third party with current formula then different product Item Code shall be given.
[][]While batch release Quality Assurance shall ensure that product requirement is fulfilled as per quality agreement during dispatch to different third party.
[][]Adequacy of impact analysis through recommendation shall be approved by Manager, Quality Assurance or Designee.
[][]For new system introduction change control shall be raised upon finalization of draft SOP.
Approval :
[][]All change controls shall be approved by Manager, Quality Assurance.
[][]Upon ensuring all approval, the originating department shall initiate preparatory work as recommendation provided to execute the changes proposed.
[][]The Quality Assurance Executive or his Designee shall review / verify all required actionable mentioned in the impact analysis(possible impact) that are required to be in place before implementation of proposed changes and provide execution approval by signing the change control.
[][]Originating department shall start to execute or implement the change only after getting approval for execution from Quality Compliance. The approved change control shall be provided to change initiator for execution of changes.
CAPA (Corrective Action and Preventive Action) Issuance and Monitoring :
[][]Quality Assurance shall issue CAPA form for long term corrective action and preventive action(s) to the concern impacted Department Head to monitor the recommendation as applicable.
[][]The CAPA shall be issued based on discretion of Manger, Quality Assurance.
Execution :
[][]Details of changes shall be explained by Quality Assurance personnel to concern persons either through mail or by conducting training as recommended in impact analysis / by sending scanned copy of change control form through mail.
[][]The concern person shall execute the change in coordination with Quality Assurance & shall prepare assessment report / data.
Review of Recommendations :
[][]After execution of the change the Concern Department Head and the impacted Department Head shall submit the CAPA form along with respective supporting data / assessment report if applicable to Quality Assurance for review of recommendations.
Impact Evaluation and Conclusion :
[][]Based on review of data / assessment report / outcome / results (satisfactory / not satisfactory) Quality Assurance shall make final conclusion, whether the change was executed successfully or not and shall close the same.
Time Line for Closure of Change Control Form :
[][]After the change is implemented, then the CC form shall be closed by Quality Assurance personnel, within 30 calendar days.
[][]Quality Assurance shall track the open change controls while issuing new change control to initiating department.
[][]New change control shall not be issued if for a same system/equipment/material/product/document and same stage about 3 change controls are already open.
Updating of Change Control Register :
[][]After closing the Change Control Quality Assurance shall update the Change Control register.
[][]All the Change Controls – Permanent / Temporary shall be retained in Quality Assurance Department.
[][]Note: In case of a change initiated for one document which may impact other document(s), the respective document(s) can be revised with reference to the same change control initiated for mother change. The document dedicated change control number system shall not applicable in this case.
[][]In addition to mother changes other changes if required can be clubbed and a separate attachment can be attached to mother change control and all persons who have involved in approval of mother change control shall sign the addendum of mother change control.
Batch release of Change Control impacted batch:
[][]Change Control impacted batch will not be released until formal closing.
[][]Any validation/trial batches produced as supporting evidence for the change proposal will be quarantined until formal closing of Change Control proposals.
[][]In some circumstances, to allow batch release, Manager, Quality Assurance may approve concurrent release of the impacted batches through a risk assessment by the owner.
Annexure:
Annexure-I: Change Control Form
Annexure-II: Change Control Register